NCT01873391

Brief Summary

The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
603

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 1, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

9 months

First QC Date

June 1, 2013

Last Update Submit

February 5, 2014

Conditions

Pain in Diagnostic Hysteroscopy

Keywords

Diagnostic hysteroscopyPainVASMultivariate analysisNormal salineCarbon dioxide

Outcome Measures

Primary Outcomes (1)

  • Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale.

    5 minutes after the procedure.

Study Arms (2)

Normal saline

ACTIVE COMPARATOR

Normal saline is a distension media of uterine cavity in diagnostic hysteroscopy.

Procedure: Diagnostic hysteroscopy

Carbon dioxide

ACTIVE COMPARATOR

Carbon dioxide is a distension media of uterine cavity in diagnostic hysteroscopy.

Procedure: Diagnostic hysteroscopy

Interventions

Diagnostic hysteroscopyPROCEDURE
Carbon dioxideNormal saline

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female gender
  • diagnostic hysteroscopy indication
  • italian-speaking patients

You may not qualify if:

  • patients who had previously undergone a diagnostic hysteroscopy
  • patients who had been previously undergone to cervical surgery
  • ongoing pregnancy
  • cervical carcinoma
  • pelvic inflammatory disease
  • excessive uterine bleeding
  • performance of an endometrial biopsy during the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arbor Vitae Endoscopic Centre

Rome, Italy, 00191, Italy

Location

Related Publications (1)

  • Mazzon I, Favilli A, Grasso M, Horvath S, Bini V, Di Renzo GC, Gerli S. Pain in diagnostic hysteroscopy: a multivariate analysis after a randomized, controlled trial. Fertil Steril. 2014 Nov;102(5):1398-403. doi: 10.1016/j.fertnstert.2014.07.1249. Epub 2014 Sep 18.

    PMID: 25241369DERIVED

MeSH Terms

Conditions

Pain

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Sandro Gerli, MD

    University Of Perugia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 1, 2013

First Posted

June 10, 2013

Study Start

May 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

IT(1)